Senior Supplier Quality Engineer, Process Validation & Test Methods
Core
Leading supplier quality engineering and process validation for critical components in transcardiac valve therapies to ensure product safety and regulatory compliance.
Role type
Senior Supplier Quality Engineer (Process Validation & Test Methods)
Builds
Qualified supplier components and validated test methods for transcardiac valve therapy devices.
Domain
Medical Device / Cardiovascular Therapies
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality management, Process validation (IQ/OQ/PQ), Test method development, Statistical analysis (Gage R&R, SPC), FMEA development, Root cause analysis, GD&T interpretation, Supplier audit management, CAPA management, Six Sigma tools
Preferred skills
FDA 21 CFR Part 820 knowledge, ISO13485/ISO9001 standards, Design controls, Injection molding/extrusion/machining processes, Optical measurement equipment, SolidWorks
Technologies
SolidWorks, Optical measurement equipment
Responsibilities
Lead gage studies and process capability studies for critical components, Develop and validate test methods and inspection fixtures, Manage supplier qualification activities from initiation to closure, Conduct on-site supplier audits, Manage supplier non-conformances and corrective action requests (SCAR), Support component specification development and risk management activities, Report on supplier part qualification status to cross-functional teams
Seniority
Senior, hands-on IC